Sue Desmond-Hellmann, AP Images

Sue Desmond-Hell­mann says it's time for her to leave the Gates Foun­da­tion. Strat­e­gy chief Mark Suz­man will now take the helm

Su­san Desmond-Hell­mann, the long­time re­searcher and ex­ec­u­tive who helped lead Genen­tech to de­vel­op the first gene-tar­get­ed can­cer ther­a­pies, is step­ping down af­ter 5 years as CEO of the Bill & Melin­da Gates Foun­da­tion.

Step­ping down as CEO of@Gates­Foun­da­tion is, with­out a doubt, the tough­est de­ci­sion of my ca­reer,” she wrote in the first of a se­ries of tweets an­nounc­ing and re­flect­ing on her de­par­ture. “But one of my mantras is ‘take your own pulse first.’ Over the last few months, I’ve done just that and con­clud­ed that I need to slow down.”

Mark Suz­man

Mark Suz­man, the foun­da­tion’s pres­i­dent of Glob­al Pol­i­cy & Ad­vo­ca­cy and chief strat­e­gy of­fi­cer, will now take over as the new CEO. Suz­man joined the foun­da­tion 12 years ago and takes the new role of­fi­cial­ly on Feb­ru­ary 1, 2020.

Desmond-Hell­mann was named CEO of the mas­sive char­i­ty in 2013, af­ter years at the top of Genen­tech and a stint as the first woman chan­cel­lor of the Uni­ver­si­ty of Cal­i­for­nia San Fran­cis­co. She was the first physi­cian to lead the foun­da­tion and dur­ing her tenure launched what was billed as the first non­prof­it biotech, the Gates Med­ical Re­search In­sti­tute, a move she re­called as one of her top achieve­ments.

Re­cent­ly, the long­time re­searcher cut down on work out­side the foun­da­tion and said to­day she was leav­ing to fo­cus on her­self and her fam­i­ly.

Desmond-Hell­mann got her start in med­i­cine as a kid, hang­ing around and some­times book­keep­ing at the drug­store her par­ents owned in Reno, Neva­da. In lat­er years, she talked about how watch­ing her fa­ther in­ter­act kind­ly with the peo­ple who came in made her want to be­come a doc­tor. Af­ter she grad­u­at­ed from the Uni­ver­si­ty of Neva­da, she took an in­tern job at UCSF in 1982, her for­ma­tive years as a physi­cian spent at the be­gin­ning and cen­ter of the AIDS/HIV cri­sis. Af­ter sev­er­al years work­ing on the virus and Ka­posi’s sar­co­ma, she and her hus­band — Nicholas Hell­mann, al­so a young UCSF doc­tor — moved to Ugan­da to do sim­i­lar work.

“We were ap­proached by the Rock­e­feller Foun­da­tion to study het­ero­sex­u­al HIV trans­mis­sion in Africa, so my hus­band Nick and I sold our Hon­da Civics, sub­let our apart­ment, and hopped on a plane,” she re­called to Reuters in Ju­ly. “We were ex­treme­ly iso­lat­ed. When we came back from Ugan­da, we nev­er com­plained about any­thing ever again.”

She fell in­to drug de­vel­op­ment two years af­ter they re­turned to Nicholas’ home state of Ken­tucky, when they both took po­si­tions at Bris­tol-My­ers Squibb in Con­necti­cut in 1993. She worked on Tax­ol, a chemother­a­py drug orig­i­nal­ly de­rived from Pa­cif­ic yew bark and first FDA-ap­proved short­ly be­fore her ar­rival.

“It was like I had been train­ing my whole life for that job,” Desmond-Hell­mann told the New York Times in 2011.

At the time, Genen­tech hadn’t de­vel­oped any can­cer drugs. The lega­cy biotech brought Desmond-Hell­mann back to San Fran­cis­co in 1995 to help build that pipeline and pro­mot­ed her to chief med­ical of­fi­cer the fol­low­ing year.

Arthur Levin­son, the CEO of Genen­tech dur­ing her tenure, de­scribed her to the New York Times as a shrewd ex­ec­u­tive, who was able to use her on­col­o­gy and sta­tis­ti­cal back­ground to choose the best drugs — and was al­so able to tell re­searchers when their projects weren’t be­ing cho­sen.

“She’s a very nice per­son, so this did not come nat­u­ral­ly to her,” Levin­son said. “But she got it quick­ly. She be­came a tough leader, tough in a pos­i­tive sense. She was will­ing to make tough calls with­out much dif­fi­cul­ty.”

Over 14 years at Genen­tech, she over­saw the de­vel­op­ment of Avastin and Her­ceptin, the first gene-tar­get­ed can­cer ther­a­pies.

She left the com­pa­ny when it was bought out by Roche in 2009, leav­ing as head of prod­uct de­vel­op­ment, and soon went on to be­come chan­cel­lor of UCSF (where there was a brief con­tro­ver­sy over her to­bac­co in­vest­ments, which she im­me­di­ate­ly sold off.). She joined the Gates Foun­da­tion in 2014.

As CEO she over­saw a bevy of pub­lic health pro­grams and, in 2018, the launch of the Gates Med­ical Re­search In­sti­tute in Cam­bridge, MA, lur­ing ex­ec­u­tives from No­var­tis and Mer­ck and oth­er top biotech firms to fill out the lead­er­ship team.

The in­sti­tute launched with a bud­get of $100 mil­lion and tar­gets the Gates Foun­da­tion had long pur­sued: malar­ia, tu­ber­cu­lo­sis, and di­ar­rheal dis­eases. The idea was to help di­rect­ly de­vel­op drugs that the mar­ket wasn’t in­cen­tiviz­ing, in­clud­ing a malar­i­al vac­cine. Their first big project is test­ing if a boost­er shot of Bacil­lus Cal­mette-Guérin, the tu­ber­cu­lo­sis vac­cine al­ready giv­en to in­fants, could help im­prove im­mu­ni­ty for ado­les­cents.

“What keeps me awake is we have all this cap­i­tal, we have all this op­por­tu­ni­ty and we bet­ter get some­thing done,” Desmond-Hell­mann told Forbes last year. “We bet­ter do some good in the world, or I will not feel good about lead­ing in the Gates Foun­da­tion.”

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Brex­it fears, Wood­ford woes over­shad­owed UK biotech and cut 2019 fi­nanc­ing by al­most half

The venture tide might have subsided, the IPO window may be closing and certain listed biotechs may be having a tough time amid Neil Woodford’s well-publicized demised, but there’s still plenty to celebrate in the UK BioIndustry Association’s eyes.

Overall investment in UK biotech last year fell from the record-breaking £2.2 billion levels of 2018 to £1.3 billion — including £679 million in venture capital, a meager £64 million in IPOs plus £596 million when you add up all public financings, according to a new report from the BIA.

Blue­print Med­i­cines po­ten­tial­ly de­lays Ay­vak­it de­ci­sion; Con­trol beats treat­ment in mesothe­lioma tri­al

→ Blueprint Medicines filed an amendment to its application to get the gastrointestinal stromal tumor (GIST) drug Ayvakit approved in fourth-line GIST, the company disclosed in the prospectus for a new $325 million public offering.  Blueprint got a big accelerated OK on the drug this month in a particular mutation, but because the FDA decided to split their review in two, they didn’t hear on fourth-line GIST. They were supposed to hear before February 14, but this amendment could push that date back by 3 months. Blueprint wrote that the amendment is designed to allow the company to comply with the FDA’s request for data from the Phase III Voyage trial before they give a judgment.

Io­n­is, Akcea boost­ed by a pos­i­tive PhII for their No­var­tis castoff car­dio drug — and they plan to push ahead in­to piv­otals

Late last year Novartis abandoned a cardio drug from Ionis’ spinoff Akcea just after the pharma giant snapped up inclisiran, going the RNAi way in guarding against heart disease in the $9.7 billion Medco buyout.

Now the pharma goliath — which is headed down the PCSK9 road with a drug it believes can be used in a mass population — can get a clearer picture of just what they gave up.

Akcea $AKCA and the mother company $IONS put out a statement early Wednesday saying that their Phase II study of AKCEA-APOCIII-LR delivered solid efficacy data, with the high dose clearly outperforming placebo in significantly reducing triglycerides as a means to cutting the risk of cardiovascular disease. In addition, investigators concluded that the drug slashed apoC-III, very low-density lipoprotein and remnant cholesterol while boosting “good” HDL levels.

Hal Barron and Emma Walmsley, GSK

GSK’s ‘break­through’ BC­MA can­cer drug gets a pri­or­i­ty re­view — and a big win for the on­col­o­gy R&D team

After largely whiffing the past 2 years on the pharma R&D front, GlaxoSmithKline research chief Hal Barron has seized boasting rights to a key win that puts them back in the cancer drug development game.

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Who are the young bio­phar­ma lead­ers shap­ing the in­dus­try? Nom­i­nate them for End­points' spe­cial re­port

Update: Nominations open through end of day, Monday, January 27

Two years ago, when we did our first Endpoints 20-under-40, we profiled a set of up-and-comers who promised to help reshape the industry as we know it. Now we’re back and once again looking for the top 20 biopharma professionals under the age of 40. We’ll be profiling folks who have accomplished a lot at a young age but seem on the verge of accomplishing so much more.